CN102824593B - Chinese patent medicine for treating chronic renal failure - Google Patents
Chinese patent medicine for treating chronic renal failure Download PDFInfo
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Abstract
The invention discloses a Chinese patent medicine for treating chronic renal failure. The Chinese patent medicine is prepared from the following raw material medicines: 375 parts of radix pseudostellariae, 187.5 parts of radix astragali, 187.5 parts of rehmannia, 187.5 parts of fructus corni, 187.5 parts of rhizoma alismatis, 187.5 parts of Indian buead, 125 parts of rhizoma dioscoreae, 375 parts of radix salviae miltiorrhizae, 125 parts of prepared rhubarb and 75 parts of fructus amomi by the following steps of: 1, grinding the fructus amomi, adding water, performing steam distillation, extracting the volatile oil, and keeping the dregs and aqueous solution for use; 2, performing inclusion on the volatile oil with beta-cyclodextrin, refrigerating, filtering and drying at low temperature for use; 3, adding water to the dregs obtained in the first step and the remaining nine medicines and decocting, combining the filtrate with the kept aqueous solution, then concentrating into thick paste, performing reduced-pressure drying, and grinding into fine powder; and 4, uniformly mixing the materials obtained in the steps 2 and 3, adding aspartame and dextrin, mixing uniformly, granulating, and drying to obtain the Chinese patent medicine. The Chinese patent medicine disclosed by the invention has the advantages of replenishing qi and nourishing yin to treat the weakened body resistance and activating blood and eliminating turbid while considering the excessive pathogen, and does not hurt the healthy qi after long-time use.
Description
Technical field
The present invention relates to Chinese medicine, especially relate to a kind of Chinese patent medicine for the treatment of chronic renal failure.
Background technology
Chinese medicine thinks, chronic renal failure great majority are the disease of deficiency in origin and excess in superficiality, and weakened body resistance is this, and the domination of pathogen is mark.Weakened body resistance aspect majority think and belong to deficiency of spleen-YANG and kidneyYANG, deficiency of both QI and YIN, the hepatic and renal YIN deficiency, deficiency of both YIN and YANG; Domination of pathogen aspect focuses mostly in the understanding to turbid damp, blood stasis, aqueous vapor, but exists the difference of emphasizing blood stasis and paying attention to turbid damp; Also there is scholar to propose the pathogenesis understanding of " the empty stasis of blood is this, and turbid damp is mark ".In the chronic renal failure course of disease, damp and hot delay can cause multiple variation.Wet and feel frustrated, hear rate the moon, with the passing of time must cause the dark consumption of gas, healthy energy interior-deficiency.Damp and hotly also can call together mutually with exopathogen, diseases caused by exogenous pathogenic factor clump is risen; Damp and hot being jammed, functional activity of QI being not smooth, blood is obstructed, and causes blood stasis and produces.Therefore, blood stasis is the key factor of chronic nephritis state of an illness progress.From theory of Chinese medical science, blood stasis is no doubt unable relevant with the prolonged illness deficiency of vital energy, fortune blood, but in the development of chronic renal failure, main is " diseases caused by retention of the body fluid blood is also sick ", and with the passing of time damp and hot, venation is unfavorable, long-pending and be the stasis of blood.Primary disease is weakened body resistance is in a word this, and the domination of pathogen is mark, empty, turbid, the stasis of blood, poison four large factor reciprocal causations, formation vicious cycle.
The understanding of the traditional Chinese medical science to chronic renal failure at present, most of doctors think that deficiency of spleen-YANG and kidneyYANG is it, and turbid damp, retention of heat in the interior are its mark, and in treatment, take warming and recuperating the spleen and kidney, damp eliminating the turbid descending, clearing away heat-damp and promoting diuresis, blood circulation promoting and blood stasis dispelling is the main rule for the treatment of more.Also there is doctor to think, spleen renal failure lose and due to damp and hot, the weakened body resistance stagnation of QI due to all empty, the noxious water turbid damp of the negative and positive of qi and blood of (or develop) and transconversion into heat thereof and and turbid damp between stagnation of blood stasis, mechanism of qi due to vicious cycle contrary be disorderly the main aspect of its deficiency in origin and excess in superficiality pathogenesis, thereby be summarised as the void of chronic kidney hypofunction, wet, the stasis of blood, contrary four large pathogenesis.
Based on for many years face card experience, we think because the course of disease of chronic renal disease is longer, no matter the deficiency of vital energy or the deficiency of YIN often due to deficiency of YIN affecting YANG, deficiency of YANG affecting YIN, and change to deficiency of both QI and YIN; Deficiency of both YIN and YANG is further developing of syndrome of deficiency of both qi and yin, and spleen kidney qi (sun) void or the hepatic and renal YIN deficiency are along with the passing of the course of disease, also constantly to deficiency of both QI and YIN, are transforming; Therefore deficiency of both QI and YIN with and further develop deficiency of both YIN and YANG, substantially represented the weakened body resistance pathogenesis of chronic renal failure, the key of its pathogenesis especially of deficiency of both QI and YIN.The kidney being a water ZANG-organ, deficiency of kidney-QI, loses in transpiration gasification, can not separating clear and excreting turbid, so that water turbid damp heresy is cohesion, excess caused by deficiency.And usually impairing the spleen and stomach of the domination of pathogen, the spleen being the foundation of acquired constitution, it is strong that insufficiency of the spleen transporting is lost, and with the passing of time retention of water-damp in the body accumulates and forms turbidly, stays in accumulation body.As can be seen here, turbid damp is to run through primary disease pathological factor all the time.Pathological changes internal organs have at lung, spleen, different at kidney, but internal organs disturbance in functioning of QI, water retention is the common pathomechanism of azotemia.Therefore hold chronic renal failure syndrome of deficiency of both qi and yin and take into account the domination of pathogen treatments such as its common turbid damp, damp and hot, blood stasis, to delaying and preventing that the progress of chronic renal failure is most important.
Summary of the invention
The object of the present invention is to provide a kind of supplementing QI and nourishing YIN weakened body resistance to control it, activating blood circulation to eliminate turbid can be taken into account its domination of pathogen, makes a distinction between the important and the lesser one, the Chinese patent medicine of the treatment chronic renal failure of compatibility harmony.
For achieving the above object, the present invention can take following technical proposals:
The Chinese patent medicine for the treatment of chronic renal failure of the present invention is to be prepared from according to following weight parts proportioning and method by crude drug Radix Pseudostellariae, the Radix Astragali, Radix Rehmanniae, Fructus Corni, Rhizoma Alismatis, Poria, Rhizoma Dioscoreae, Radix Salviae Miltiorrhizae, Radix Et Rhizoma Rhei and Fructus Amomi:
Proportioning: 375 parts of Radix Pseudostellariaes, 187.5 parts of the Radixs Astragali, 187.5 parts of Radix Rehmanniae, 187.5 parts of Fructus Corni, 187.5 parts of Rhizoma Alismatis, 187.5 parts, Poria, 125 parts of Rhizoma Dioscoreaes, 375 parts of Radix Salviae Miltiorrhizaes, 125 parts of Radix Et Rhizoma Rhei, 75 parts of Fructus Amomis;
Preparation method:
The first step, pulverizes Fructus Amomi, adds 6 times of amounts of water, and steam distillation 6 hours extracts volatile oil, and medicinal residues and aqueous solution are continued to employ;
Second step, by cold preservation after betacyclodextrin inclusion 24 hours for first step gained volatile oil, filters, standby after cold drying;
The 3rd step, the medicinal residues that the first step is continued to employ decoct with water three times together with residue nine taste medicines, after the aqueous solution that filtrate and the first step are continued to employ merges, are concentrated into the thick paste of relative density 1.3-1.35, are ground into fine powder after drying under reduced pressure;
The 4th step, will add 10 parts of aspartames after second step and the 3rd step gained material mix homogeneously, and dextrin is appropriate, routinely technique mix homogeneously, granulation, obtain Chinese patent medicine after dry.
The invention has the advantages that holding chronic renal failure syndrome of deficiency of both qi and yin takes into account the domination of pathogen treatments such as its common turbid damp, damp and hot, blood stasis, in this granule side, Radix Pseudostellariae supplementing QI and nourishing YIN is to be monarch drug; Radix Astragali invigoration spleen qi, Radix Rehmanniae nourishing kidney-yin is to be ministerial drug; Fructus Corni nourishing kidney the liver benefiting, Rhizoma Alismatis is joined the Radix Rehmanniae and rushes down kidney the turbid descending, and Poria is joined Rhizoma Dioscoreae and to ooze spleen wet; Fructus Amomi can the anti-Radix Rehmanniae greasy, again can eliminating turbid pathogen with aromatics, appetizing; Radix Salviae Miltiorrhizae nourishing blood and promoting blood circulation; Make a distinction between the important and the lesser one, compatibility harmony, all medicines share, and play altogether the effect of supplementing QI and nourishing YIN, activating blood circulation to eliminate turbid.Supplementing QI and nourishing YIN is weakened body resistance to control it, and activating blood circulation to eliminate turbid can be taken into account its domination of pathogen, and life-time service is without hindering healthy energy.
The present invention is according to the physicochemical property of medicine and drug effect toxicological study, determined Fructus Amomi water vapour distillation volatile oil, medicinal residues and all the other nine tastes decoct with water the extraction process of extraction, got rid of the process of " alcohol extraction+decocting " that have obvious acute toxic reaction suspicion, guaranteed that drug effect is safer again.The mobile phase of the granular preparation going out according to explained hereafter of the present invention is good, is difficult for moisture absorption at envionmental humidity below 59%.
The specific embodiment
The Chinese patent medicine for the treatment of chronic renal failure of the present invention is by crude drug Radix Pseudostellariae 375g, Radix Astragali 187.5g, Radix Rehmanniae 187.5g, Fructus Corni 187.5g, Rhizoma Alismatis 187.5g, Poria 187.5g, Rhizoma Dioscoreae 125g, Radix Salviae Miltiorrhizae 375g, Radix Et Rhizoma Rhei 125g, Fructus Amomi 75g is prepared from:
The first step, is broken into coarse granule by amomum powder, adds 6 times of amounts of water, and steam distillation 6 hours extracts volatile oil, and medicinal residues and aqueous solution are continued to employ;
Second step, by first step gained volatile oil betacyclodextrin inclusion (volatile oil: betacyclodextrin: water=1:8:80, stirs 1 hour by 60 ℃), cold preservation 24 hours, filters, and 35-40 ℃ is dry rear standby;
The 3rd step, the medicinal residues that the first step is continued to employ decoct with water three times together with residue nine taste medicines, each 1 hour, add 10 times of amounts of water, after the aqueous solution that three filtrate and the first step are continued to employ merges, be concentrated into the thick paste of relative density 1.30-1.35, be decompressed to-0.1MPa crushed after being dried becomes fine powder;
The 4th step, will add aspartame 10g after second step and the 3rd step gained material mix homogeneously, and dextrin is appropriate, and technique mix homogeneously, granulation 1000g routinely obtain Chinese patent medicine after being dried.
Instructions of taking and taboo: warm boiled water, every day 3 times, each 10 grams.Anemia of pregnant woman and child are cautious use of.
1, the quality standard research of preparation of the present invention:
The present invention's medical material used is medical material that records of < < Chinese Pharmacopoeia > > version in 2005, the experiment proved that and meet pertinent regulations under corresponding medical material item of < < Chinese Pharmacopoeia > > version in 2005, the Radix Astragali is measured a lower operation with finished product content, with high effective liquid chromatography for measuring, carry out assay, and should meet pharmacopeia limit regulation.
Clinical research by the regulation of < < provisions for new drugs approval > > and " Chinese medicine, natural drug stability study technological guidance principle ", is carried out methodological study by drug quality draft standard.For the contained flavour of a drug of new drug, set up the thin-layer identification method of Radix Pseudostellariae, the Radix Astragali, Fructus Corni, Rhizoma Alismatis, Radix Salviae Miltiorrhizae, Radix Et Rhizoma Rhei, Fructus Amomi in preparation; The assay of preparation has been set up to the content assaying method of effective ingredient astragaloside in the preparation take HPLC as means, and set up method is comprised to the serial of methods such as standard curve, precision, stability, repeatability, the response rate investigates, the establishment of having confirmed method; Through many batch samples are measured, tentatively having worked out content limit standard is that every bag of 8g of this product contains the Radix Astragali in astragaloside (C41H68O14), must not be less than 0.30mg.Because of Astragaloside content less than ten thousand/, therefore measured again n-butanol extract, tentatively worked out content limit standard and be this product and contained n-butanol extract and must not be less than 2.5%.
Result shows: the stable easily row of this standard, controllability is strong, reproducible, can control the quality of preparation of the present invention.
2, the stability study of preparation of the present invention:
By the regulation of the relevant technologies requirement to long term test in < < provisions for new drugs approval > > and two appendix XIX C medicine stability test guidelines of < < Chinese Pharmacopoeia > > version in 2005, carry out study on the stability research.
2.1 Journal of Sex Researchs steady in a long-term: investigate the preliminarily stabilised implementations of preparation of the present invention under simulation commercially available back condition.To this preparation granules three batch samples (lot number 050601,050603,050605) by under quality standard for clinical research (draft) and appendix IL tablet item of Chinese Pharmacopoeia version in 2005 and X III C microbial limit test detect, take of that month testing result as 0 month result, natural storage 18 months under room temperature, the 0th, 3,6,12,18 months investigate once.The project of investigating has: character, discriminating, inspection (moisture, content uniformity, disintegration, microbial limit), n-butanol extract and assay.Result shows: indices, without significant change, illustrates that said preparation quality is basicly stable.
2.2 acceleration for stabilization Journal of Sex Researchs: to preparation granules three batch samples of the present invention (lot number 061010,061012,061014) by under quality standard for clinical research (draft) and appendix IL tablet item of Chinese Pharmacopoeia version in 2005 and X III C microbial limit test detect, take of that month testing result as 0 month result, in 40 ℃ ± 2 ℃ of temperature, under the condition of relative humidity 75% ± 5%, place.Respectively at 0,1,2,3,6 month, investigate once.The project of investigating has: character, discriminating, inspection (moisture, content uniformity, disintegration, microbial limit), n-butanol extract and assay.Result shows: indices, without significant change, illustrates that said preparation quality is basicly stable.
The preparation of 2.3 pilot scale three batch samples
According to definite technique, produce three batch samples (lot number 061010,061012,061014), through checking whole conformance with standard regulations.Illustrate that this preparation technology is suitable for suitability for industrialized production.
3, pharmacodynamic experiment result
For determining the pharmacological action of prescription, according to its function, cure mainly, select animal model, and in conjunction with the detection of corresponding diagnosis index, investigate its pharmacodynamics.In research process, adopt respectively 0.75% adenine forage feed method and 5/6 nephrectomy legal system for chronic renal failure animal model.The mechanism that 0.75% adenine causes Renal Function in Rats exhaustion may be metabolite crystallization deposition damage renal tubules and interstitial, causes renal hypofunction.5/6 nephrectomy causes Renal Function in Rats exhaustion model and meets glomerule height filtration rate to cause renal failure theory (be that HT, high filtration and high pressure appear in remaining nephron, and then the further destruction that causes glomerular sclerosis and remaining nephron), thereby relatively approach clinical practice.Two kinds of animal models are simulated clinical common disease performance substantially.
According to the requirement of existing < < study of tcm new drug technical manual (pharmacy pharmacology's toxicology) > >, complete following test:
The impact of 3.1 preparation granules Adenine-Induced Chronic Renal Failure in Rat animal patterns of the present invention
3.1.1 research method:
Getting body weight is 100 of 110～130g male rats, freely drinks water for 20 as normal control animal, edible conventional feed; All the other animals, for the preparation of animal pattern, freely drink water, the edible 0.75% adenine feedstuff that contains, and every rat (about 150g body weight) is calculated by 1 day edible 10 grams of piece material, takes in adenine amount every day and is about 75mg, observes the daily situation of urine amount and rat.After 4 weeks, randomly draw 8 of 10 of modeling treated animals and normal group animals, get blood, detect serum urea nitrogen (BUN) and creatinine (Crea), measure kidney organ index, to prove the success of model.After checking modeling success, residue modeling animal is got to blood from vena orbitalis posterior clump, measure the content of serum BUN and Crea, and adjust 5 groups of modeling rats according to its numerical value, make its index significance test without significant difference, 5 groups are respectively the large, medium and small dosage group of model control group, NIAODUQING KELI matched group and preparation granules of the present invention, will remain normal control treated animal as blank group, totally 6 groups, 12 every group.All animals all normally freely drink water, the conventional feed of feeding.By different dosing dosage, gavage preparation granules of the present invention, large, medium and small dosage is respectively 11.27g crude drug/kg, 5.64g crude drug/kg and 2.82g crude drug/kg and NIAODUQING KELI 5g medicated powder/kg, blank group and model group gavage deionized water, gavage 30 days continuously, during administration, record the variation of the weight of animals and amount of drinking water.
During administration 21 days, from vena orbitalis posterior clump, get blood, measure the hematological indices of each treated animal, comprise erythrocyte (RBC), hemoglobin (HGB), packed cell volume (HCT), mean corpuscular volume (MCV) (MCV) and mean corpuscular hemoglobin (MCH), investigate this product whether Anemia of Chronic Renal Failure is improved to effect.
During administration 23 days, measure the phenol red excretion rate of each treated animal, in order to investigate ERPF.Phenol red (PSP) normal saline solution of each treated animal tail vein injection 0.6%, injected dose is 0.8ml/100g body weight, respectively after injection when 2min and 32min, from vena orbitalis posterior clump, get blood 1ml, with heparin 10 μ l anticoagulants, centrifugal, get blood plasma 0.2ml, dilute with diluent (NS:1M NaOH=29:1) 3ml, 560nm place colorimetric, the PSP absorbance of two time points of mensuration, (concentration is respectively 0.2 to adopt standard curve method, 0.5,1,2,5,10,20 μ g/ml) calculate the concentration of PSP in blood plasma
c 0(2min) and
c t(32min), by formula b=(
c 0-
c t)/
c 0, calculate the phenol red excretion rate (b) of each treated animal.
Respectively when administration 28,29,30 days, each every group of 4 animals, water is can't help in fasting, leaves and takes 12 hours urines of each treated animal, measures urine amount; Test strips method checks urine, records urine specific gravity (SG) and pH value; Measure urine Na
+, K
+, CL
-content, and according to uri-meter calculate 12 hours total outputs; Measure the content of urine protein, and calculate 12 hours total urinary protein amounts according to uri-meter.
During administration 30 days, get each group of all animals, weigh in, put to death after getting blood, anatomic observation kidney, and weigh kidney weight, and calculate kidney organ index, by neutral formalin, fix, carry out histopathology observation.Centrifugal, separation of serum, measures serum urea nitrogen (BUN), inosine (Crea) content, observes the pharmacological action of this product.
3.1.2 result of study:
the impact of preparation granules of the present invention on Adenine-Induced Chronic Renal Failure in Rat animal pattern body weight:during rats eating adenine, body weight gain is slow, and chaeta comes off, lethargy, and urine amount increases gradually.After grouping administration, respectively organize the modeling animal 0.75% adenine feedstuff that stops feeding, after changing normal mice material into and raising, animal body weight average has growth.Before administration, with the comparison of blank group, each administration group and model group body weight difference have significant (
p<0.01), model group and each administration group body weight no difference of science of statistics (
p>0.05); After administration, the 1st thoughtful the 3rd week, administration treated animal body weight gain speed, each administration treated animal body weight and model group comparison, difference have significant (
p<0.01); Animal chaeta is glossy, and the mental status is better.The results are shown in subordinate list 1.
the impact of preparation granules of the present invention on Adenine-Induced Chronic Renal Failure in Rat animal pattern amount of drinking water:before administration, each group model drinking water for animals amount and obvious the increasing of blank group amount of drinking water (
p<0.05).The 2nd week small dose group drinking water for animals amount of administration reduces, with blank treated animal comparing difference have significant (
p<0.05), administration the 3rd week, the amount of drinking water of each administration treated animal be all less than model group drinking water for animals amount (
p<0.05,
p<0.01).The results are shown in subordinate list 2.
the impact of preparation granules of the present invention on Adenine-Induced Chronic Renal Failure in Rat animal pattern hematological indices:administration is got blood for 21 days and is observed, and administration treated animal makes moderate progress because of Anemia of Chronic Renal Failure situation.RBC, HGB, the HCT of heavy dose of treated animal are higher, with the comparison of model group animal These parameters, difference have significant (
p<0.05,
p<0.01); The HCT of small dose group is higher, with the comparison of model group animal corresponding index, difference have significant (
p<0.05,
p<0.01).The results are shown in subordinate list 3.
the impact of preparation granules of the present invention on Adenine-Induced Chronic Renal Failure in Rat animal pattern urine index:administration 30 days, gets the uroscopy of 12 hours of each treated animal, with the comparison of model group animal, 12 hours urine amounts of the large, medium and small dosage treated animal of preparation granules of the present invention, 12 hours sodium, chlorine, urinary protein excretion total amount all significantly lower than model group (
p<0.01); The urine specific gravity value of heavy dose of treated animal higher than model group animals urine rate of specific gravity (
p<0.05).The results are shown in subordinate list 4.
the impact of preparation granules of the present invention on Adenine-Induced Chronic Renal Failure in Rat animal pattern Biochemical Indices In Serum:administration 30 days, gets blood, measures the content of BUN and Crea in serum, and result shows, in the each dosage treated animal of preparation granules of the present invention serum BUN and Crea value all significantly lower than model group animal (
p<0.05,
p<0.01), and significantly lower than the value of These parameters in animal serum before administration.The results are shown in subordinate list 5.
the impact of preparation granules of the present invention on Adenine-Induced Chronic Renal Failure in Rat animal pattern kidney:feed 0.75% adenine after 4 weeks, get the inspection that becomes celestial of 16 rats, blank treated animal kidney is fabiform, and surface color is dark red, and quality is softer, and tangent plane cortex is dark red, medullary substance light red, and cortex and medullary substance boundary are clear; The swelling of modeling animal kidney, quality is harder, and surface is canescence, and is the graininess change of uniformity, and tangent plane is canescence, and cortex and medullary substance boundary are visible.
Administration 30 days, put to death each treated animal, observation becomes celestial, blank treated animal kidney is without significant change, model control group animal kidney is there are no obvious recovery, all there is the graininess texture of red, Bai Xiangjian in various degree in each administration treated animal kidney surface, tangent plane drug crystallization deposition in various degree as seen; It is in renal cortex renal tubules and kidney interstitial, to have a large amount of yellow green crystallization depositions that pathological section microscopy is observed model control group rat kidney major lesions, forms foreign body granuloma centered by crystallization, visible multinucleated giant cell and epithelioid cell in granuloma.Tubular ectasia (renal cortex portion is mainly Distal convoluted tubule expansion),, there is protein cast in kidney interstitial proliferation.Except blank group has no pathological change, each administration treated animal nephropathy type is identical with model control group, but lesion degree difference.On inspection, in above-mentioned pathological changes, with tubular ectasia degree, respectively organize obvious difference, therefore using tubular ectasia degree as semiquantitative index, formulate grading standard, carry out comparing between each test group.Through observing and measuring, blank group renal tubules tube chamber minor axis is all less than 10 μ m, when the renal tubules minor axis that occurs to expand is 60 μ m, its degrees of expansion clearly, therefore using the number of minor axis >=60 μ m renal tubules as grade scale, i.e. renal cortex same area is selected in every section (1 section of every animal), under 400 times of light microscopics, 10 visuals field of Continuous Observation, measure renal tubules tube chamber minor axis with micrometer in each visual field, the renal tubules quantity of counting minor axis >=60 μ m.Sxemiquantitative grade scale is: count results is 0 and is designated as-; Count results is 1 ~ 15 and is designated as+; Count results is 16 ~ 30 and is designated as ++; Count results is 30 and is designated as above +++.With model control group comparison, the heavy dose of treated animal tubular ectasia of preparation granules of the present invention degree light (
p<0.05); Calculate kidney organ index, the kidney organ index of each administration treated animal and the comparison of model control group animal, no significant difference (
p>0.05).The results are shown in subordinate list 6.
the impact of preparation granules of the present invention on Adenine-Induced Chronic Renal Failure in Rat animal pattern ERPF:administration 23 days checks, result of the test shows, the phenol red excretion rate of animal of the large, medium and small dosage group of preparation granules of the present invention is all higher than model group animal, difference have significant (
p<0.01), show that the ERPF of administration treated animal is larger.The results are shown in subordinate list 7.
The impact that 3.2 preparation granules of the present invention exhaust rat 5/6 renal cortex excision induced CRF
3.2.1 research method:
Get 150 of body weight 160 ~ 180g male rats, get 22 for normal control treated animal, residue animal surgery excises 5/6 Renal Cortex, causes chronic renal failure animal pattern.Modeling treated animal, is performed the operation after 1 week at this laboratory rearing, with 4% chloral hydrate intraperitoneal injection of anesthesia, dosage is 0.5ml/, and veutro clinostatism, at dorsal part, by incision of skin, expose left kidney, by the renal cortex excision of upper and lower left kidney two utmost points and a side, approximately retain 1/3 renal cortex, but do not damage renal pelvis part, with gelfoam hemostasis, determine without after hemorrhage, send in body stitched backing pleural muscle layer skin.This operation was carried out after 1 week, and same back otch, exposes right kidney, and peplos is peeled off, and retains adrenal gland, by silk thread ligation renal blood vessels, by Resection of right kidney.After modeling, animal is all normally raised, and observes the general status of animal.After 16 weeks, get animal pattern and normal control treated animal, get blood, the content of BUN and Crea in detection serum, for proving the establishment of model.After model is set up, model group animal is pressed to the content of BUN and Crea in serum, evenly being divided into 5 groups is model control group, NIAODUQING KELI matched group, the large, medium and small dosage group of preparation granules of the present invention, adjust animal, make its index significance test without significant difference, get 12 normal control treated animals, totally 6 treated animals, every group 12, the medicine (dosage is with 7.1) that gives respectively various dose, blank group and model group gavage deionized water, continuously gavage 6 weeks, during administration, observe animal general status, record the variation of 4 weeks body weight and amount of drinking water.
During administration 4 weeks, get each treated animal, leave and take 12 hours urines, measure urine amount, test strips method checks urine, records urine specific gravity (SG) and pH value, measures the content of urine protein, and calculates 12 hours total urinary protein amounts according to uri-meter.With 4% chloral hydrate intraperitoneal injection of anesthesia, from vena orbitalis posterior clump, get blood, centrifugal, separation of serum, measures blood urea nitrogen (BUN), total protein (TP), albumin (ALB), inosine (Crea).
During administration 6 weeks, get each treated animal, weigh in, abdominal vein is put to death after getting blood, anatomic observation kidney, and weigh kidney weight, and calculate kidney organ index, by neutral formalin, fix, carry out pathological observation.With anticoagulant heparin, cone-plate method is measured the viscosity of whole blood and blood plasma.
result of study
the impact of preparation granules of the present invention on Chronic Renal Failure Model in Rats the weight of animals due to 5/6 nephrectomy:modeling animal is being implemented after resection operation, and normal condition is raised 16 weeks, body weight gain.After grouping administration, the body weight change of observing administration 4 weeks animals, each administration treated animal and the comparison of model control group animal, difference there are no significant meaning (
p>0.05).The results are shown in subordinate list 8.
the impact of preparation granules of the present invention on Chronic Renal Failure Model in Rats drinking water for animals amount due to 5/6 nephrectomy:before administration, each group model drinking water for animals amount and the comparison of blank treated animal amount of drinking water, no significant difference (
p>0.05), amount of drinking water and the model control group comparison of heavy dose of treated animal after successive administration 4 weeks, amount of drinking water is more, difference have significant (
p<0.05).The results are shown in subordinate list 9.
the impact of preparation granules of the present invention on Chronic Renal Failure Model in Rats animals urine index due to 5/6 nephrectomy:after administration 28 days, get the uroscopy of 12 hours of each treated animal, in preparation granules of the present invention 12 hours urine amounts of dosage treated animal and, urinary protein excretion total amount is all significantly higher than model group, difference have significant (
p<0.05); Other administration treated animal and model group comparison, its observation index no significant difference (
p>0.05).The results are shown in subordinate list 10.
the impact of preparation granules of the present invention on Chronic Renal Failure Model in Rats animal serum biochemical indexes due to 5/6 nephrectomy:after administration 28 days, from vena orbitalis posterior clump, get the content of hematometry serum urea nitrogen (BUN), total protein (TP), albumin (ALB), inosine (Crea), testing result shows, the big or middle dosage treated animal of preparation granules of the present invention ALB, TP value are higher, with the comparison of model control group animal, difference have significant (
p<0.05,
p<0.01), the ALB value of small dose group animal also apparently higher than model control group (
p<0.01).BUN and the Crea value of the big or middle dosage treated animal of preparation granules of the present invention are starkly lower than model control group animal, difference have significant (
p<0.05,
p<0.01), the Crea value in small dose group animal serum is also significantly on the low side, with model control group comparison, difference have significant (
p<0.05).The results are shown in subordinate list 11.
the impact of preparation granules of the present invention on Chronic Renal Failure Model in Rats animal kidney due to 5/6 nephrectomy:during administration 42 days by sacrifice of animal, the observation that becomes celestial, blank treated animal kidney is fabiform, surface color is dark red, quality is softer, tangent plane cortex is dark red, medullary substance light red, cortex and medullary substance boundary are clear; Administration treated animal kidney all has swelling in various degree, and the wound healing that excision forms is good, and color is kermesinus, and the remaining cortex of tangent plane and medullary substance boundary are clear.The renal index of the big or middle dosage treated animal of preparation granules of the present invention is obviously greater than model control group, difference have significant (
p<0.05).Because modeling adopts excision mode, may have difference to affect result because of the degree of excision, therefore do pathology section examination renal tissue, change, document shows after kidney surgery modeling, pathologic finding glomerule with loose, be hardened to main feature
[6].The main pathological change of this test display model animal glomerule is glomerule hypertrophy, so adopt pathology section examination and calculate glomerule path length, and by it as observation index, the method of measuring is under light microscopic, to be amplified to 400 times, in the cross section section of kidney center, renocortical different parts is respectively got a visual field, get altogether 5 places, in every visual field, get the glomerule of a visible afferent glomerular arteriole, measure it vertical, transverse diameter length, get the path length of its meansigma methods as this glomerule, get the meansigma methods of 5 glomerule path lengths as the glomerule path length of this animal, then whether the difference of more each treated animal path length numerical value has significant.Result show, the big or middle dosage treated animal of preparation granules of the present invention glomerule path length is shorter, with model control group comparison, difference have significant (
p<0.01,
p<0.05).The results are shown in subordinate list 12.
the impact of preparation granules of the present invention on Chronic Renal Failure Model in Rats animal blood viscosity due to 5/6 nephrectomy:after administration 42 days, get each treated animal, measure blood and plasma viscosity, result of the test shows that the heavy dose of group of preparation granules of the present invention whole blood viscosity value is 200s cutting fast
-1and 100s
1time, animal's whole blood viscosity is less, with model group comparing difference have significant (
p<0.05).The plasma viscosity value of the large, medium and small animal of preparation granules of the present invention is all obviously less, with model control group comparing difference have significant (
p<0.05,
p<0.01).The results are shown in subordinate list 13.
3.3 impacts of preparation granules of the present invention on Endurance and anti-stress ability
3.3.1 impact-mice the swimming test of preparation granules of the present invention on Endurance
Get 60 of body weight 18～20g mices, male and female half and half, be divided at random 5 groups, be that the big or middle and small dose group dosage of blank group, ginseng stilbene granule matched group 2g medicated powder/kg, preparation granules of the present invention is respectively 16.1g crude drug/kg, 8.05g crude drug/kg and 4.03g crude drug/kg, blank group gives deionized water, gastric infusion 12 days continuously, after last administration 1 hour, the tank that mice is put into 15 ℃～16 ℃ carries out swimming test, afterbody bears a heavy burden, female, buck 10% and 8% of the body weight of bearing a heavy burden respectively, records persistent period of every Mus swimming.No longer to expose after head submerges in water as timing, finish.Relatively animal swimming time, as the aggregative indicator of judging mice muscle power and stress.
Experimental observation show, preparation granules of the present invention can extend the swimming time of mice, administration treated animal and the comparison of blank treated animal, the difference of swimming time have significant (
p<0.05,
p<0.01); The results are shown in subordinate list 14.
the impact of preparation granules of the present invention on mice tolerance to cold
Get 60 of body weight 18～20g mices, male and female half and half, be divided at random 5 groups, it is the big or middle and small dose group (the same 3.3.1 of dosage) of blank group, ginseng stilbene granule matched group, preparation granules of the present invention, blank group gives deionized water, gastric infusion 13 days continuously, after last administration 1 hour, every mice is respectively charged into mouse cage, put into-15 ℃ of refrigerator-freezers, by glass for refrigerator window, observe animal, record each treated animal death toll in 3.5 hours, the survival rate of more each treated animal, investigates the impact of this product on animal anti-stress ability.
Result shows, under same cold conditions condition (15 ℃), in same time, the survival rate of the heavy dose of treated animal of the present invention is higher, with blank group comparing difference have significant (
p<0.01).The results are shown in subordinate list 15.
the impact of preparation granules of the present invention on mice nonspecific immunity and humoral immune function
3.4.1 the impact on mice reticuloendothelial system phagocytic function (mice carbon clearance method)
Get 84 of body weight 18～20g healthy mices, male and female half and half, be divided at random 6 groups: blank group, model group, big or middle and the small dose group dosage of ginseng stilbene granule matched group 2g medicated powder/kg, preparation granules of the present invention is respectively 16.1g crude drug/kg, 8.05g crude drug/kg and 4.03g crude drug/kg, blank group and model control group give deionized water, within continuous 16 days, give each group of different pharmaceutical.During administration 9 days, except blank group, each treated animal intraperitoneal injection of cyclophosphamide 80mg/kg.Last gave tested material after 1 hour, each treated animal tail vein injection india ink normal saline solution (1:4 dilution), and dosage is 0.1ml/10g body weight, 1min(after injection
t 1 ) and 5min (
t 2 ), with capillary blood taking tube, from vena orbitalis posterior clump, get blood 20 μ l respectively, be dissolved in 2ml 0.1%NaCO
3in solution, shake up, put spectrophotometer in 600nm place colorimetric, measure absorbance A
1and A
2.Finally, mice is put to death, takes respectively liver, spleen weight, by following formula calculate clean up index (
k), compare.Investigate preparation granules of the present invention and whether there is immunological enhancement.
Result of the test shows, in mice carbon clearance test, the large, medium and small dosage treated animal of preparation granules of the present invention clean up index (
k) all larger, with the comparison of model group animal, difference have significant (
p<0.05,
p<0.01).The results are shown in subordinate list 16.
impact (hemolysin test method) on mouse humoral immune function
Get 18～20g mice, be divided at random 6 groups, group and administration are the same, administration in continuous 16 days.During administration 9 days, every Mus lumbar injection 5% normal saline chicken red blood cell suspension 0.2ml carries out immunity, and immunity is after 1 day, except Normal group, and each treated animal intraperitoneal injection of cyclophosphamide 80mg/kg.After immunity 7 days, pluck eyeball and get blood, centrifugal, get 100 times of serum normal saline dilutions, get dilute serum 1ml, mix with 5% chicken erythrocyte suspension 0.5ml, 10% guinea pig serum complement 0.5ml, in 37 ℃ of calorstats, be incubated 30min, 0 ℃ of refrigerator cessation reaction.Centrifugal, get supernatant, at 540nm place, measure its absorbance, using absorbance (A) reading as the index of judging serum hemolysin, the difference of relatively more each group, judges the quantity that antibody forms indirectly, determines the impact of this product on humoral immune function.
Test shows, the absorbance (A) of the big or middle dosage treated animal of preparation granules of the present invention value is higher, with the comparison of model group animal, difference have significant (
p<0.01).The results are shown in subordinate list 17.
4, the toxicity test of preparation granules of the present invention
4.1 acute toxicity test
For reflection preparation granules of the present invention is to mice toxic reaction in a short time comprehensively, acute toxicity test research is carried out in the test of employing mice maximum dosage-feeding.Under this experiment condition, select the clean level of ICR strain mice, gavage gives mice with gavage in maximum administration volume one day 1 time, dosage is that to draft the clinical day for human beings be 0.805g crude drug/kg with maximum dose level to 127.3g crude drug/kg(), be equivalent to draft 158 times of clinical administration dosage, after administration, at once observe reaction of animals, outward appearance, extremity activity, ingest, drink water, drain no abnormality seen.Continuous Observation 14 days, result mice is healthy survival all, and body weight increases, with blank group comparing difference unknown significance meaning (P>0.05).The results are shown in subordinate list 18,19.
long term toxicity test
For further studying the toxicity of preparation granules repetitively administered of the present invention, the preparation granules rat of the present invention long term toxicity test of 6 months has been carried out in this experiment, to understand the toxic reaction of preparation granules of the present invention, the situation of toxic reaction target organ, to determine nontoxic amounts of reactants, for drafting people, with safe dose, provide reference.
Under SPF level experiment condition, select clean level SD strain rat, carry out long term toxicity test, continuous 26 weeks gavages give to rat preparation granules of the present invention 40.5,20.2,10.1 g crude drug/kg/skies (being equivalent to draft 50,25,12.5 times with dosage of the clinical day for human beings), and drug withdrawal 4 weeks.MAIN OUTCOME MEASURES has:
death condition:gastric infusion 26 weeks, drug withdrawal 4 weeks, observes animal and has or not and give the toxicity death that tested material causes because of gavage.
animal general status:the situations such as the expression of daily observation animal, hair, behavior, activity, feces, secretions.
body weight and food ration:claim weekly rat body weight once, according to body weight, adjust dosage; Quantitatively add foodstuff, calculate every 100g body weight animal food ration of a day.
urine index:when the continuous gastric infusion of rat the 16th week, the 26th week and drug withdrawal the 4th week, get the each treated animal of part and put into metabolic cage, collect the urine of 12 hours, measure volume of urine and proportion, and adopt eight reagent paper of urine to check urine, detect the content that index comprises urobilinogen in urine, occult blood, bilirubin, ketoboidies, glucose, protein, pH and nitrite.
hematological indices:the continuous gastric infusion of rat the 16th week, when the 26th week and drug withdrawal the 4th week, get the each treated animal fasting of part and can't help water 16 hours, with 4% chloral hydrate intraperitoneal injection of anesthesia, extract abdominal vein blood, detect animal hematology index, comprise leukocyte (WBC), erythrocyte (RBC), hemoglobin (HGB), platelet (PLT), packed cell volume (HCT), mean corpuscular volume (MCV) (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC) (MCHC), lymphocyte (LY), mononuclear cell (MO), neutrophilic granulocyte (GR), Erythrocyte hemoglobin distribution width (RDW), thrombocytocrit (PCT), MPW (PDW), mean platelet volume (MPV), prothrombin time (PT), activated partial thromboplastin time (APTT), reticulocyte (Ret).
serological biochemical markers:the continuous gastric infusion of rat the 16th week, when the 26th week and drug withdrawal the 4th week, get the each treated animal fasting of part and can't help water 16 hours, with 4% chloral hydrate intraperitoneal injection of anesthesia, extract abdominal vein blood, after centrifugal, get serum and detect biochemical indexes, comprise ALT (ALT), aspartic acid transferring enzyme (AST), alkali phosphatase (ALP), blood urea nitrogen (BUN), total protein (TP), albumin (ALB), blood glucose (GLU), total bilirubin (T-BIL), inosine (Crea), T-CHOL (T-CHO), triglyceride (TG), creatine kinase (CK), glutamyl transferring enzyme (γ-GT), Na in serum, K, the content of CL ion.
system is dissected:the continuous gastric infusion of rat the 16th week, when the 26th week and drug withdrawal the 4th week, get the each treated animal fasting of part and can't help water 16 hours, with 4% chloral hydrate intraperitoneal injection of anesthesia, sacrificed by exsanguination after extraction abdominal vein blood, animal is carried out to gross anatomy observation, and win brain, cerebellum, brain stem, spinal cord, hypophysis, thymus, thyroid, parathyroid gland, esophagus, salivary gland, stomach, small intestinal, large intestine, liver, pancreas, kidney, adrenal gland, spleen, heart, trachea, lungs, aorta, testis, epididymis, uterus, ovary, prostate, bladder, bone marrow, optic nerve, lymph node (mesentery), the internal organs such as seminal vesicle and tissue, when dissected perusal main organs and tissue have or not abnormal pathological change, breast, each body cavity such as abdominal cavity has or not abnormal hydrops etc.
organ coefficient:after 4% chloral hydrate intraperitoneal injection of anesthesia animal, take the weight of animals.During postmortem, get respectively the heart, liver, spleen, lung, kidney, adrenal gland, brain, thymus, uterus, ovary, testis, epididymis, prostate and the seminal vesicle of above-mentioned animal and weigh, and calculate organ coefficient.
histopathologic examination:by the animal viscera of the above-mentioned gained that performs an autopsy on sb． and tissue, with neutral formalin solution fix, paraffin embedding, section, HE dyeing, the variation of its organizational structure of light microscopy checking.
After the every observation index of systematic analysis, there is not the overt toxicity reaction relevant to tested material in animal subject.Test prompting, in clinical drug application, should note drug withdrawal after the variation of triglyceride content and liver function.Medicine no-effect level can be decided to be 40.5g crude drug/kg/ days, is approximately equivalent to draft 50 times of the daily dosage of clinical people (60kg).
In sum, preparation granules of the present invention has the pharmacological action of supplementing QI and nourishing YIN, activating blood circulation to eliminate turbid; The maximum dosage of preparation granules mice of the present invention is 127.3g crude drug/kg, is equivalent to 158 times of clinical plan consumption, and under this dosage, mice is safe; The continuous gastric infusion of rat 6 months is observed, and medicine no-effect level can be decided to be 40.5g crude drug/kg/ days, is approximately equivalent to draft 50 times of the daily dosage of clinical people (60kg).
5, clinical observation
case 1:
× ×, man 48 years old.Because of " recurrent dizziness, weak more than 1 year, ammonia taste 5 months in mouthful " medical treatment.Disease is seen: dizzy weak, and the soreness of waist, food is received obvious minimizing, gastral cavilty distension, ammonia taste in mouthful, defecates 2 times/day.Body of the tongue is light red, yellow and greasy fur, stringy pulse.Have a medical check-up: BP 123/77mmHg, anemia looks; Lab testing: routine blood test: erythrocyte 2.61 × 10
12/ L, hematochrome 85g/L; Serum creatinine 811.4 μ mol/L, blood urea nitrogen 104.16mmol/L; B ultrasonic: left kidney 8.1cm × 4.1cm × 3.6cm, the thick 0.9cm of essence, right kidney 7.2cm × 4. 1cm × 3.5 cm, the thick 0.9cm of essence.
Tcm diagnosis: obstruction and rejection, dialectical is damp and hot middle resistance, lifting imbalance.Western medicine diagnose: chronic renal failure-Uremic.Patient refuses dialysis, requires Chinese traditional treatment.
Plan clearing away heat and eliminating dampness is let out turbid, and tune regulating the function of middle-JIAO is method, controls with this prescription.1 dose of every day, take 2 times (be equivalent to granule one day dose 30 grams).Western medicine gives anti symptom treatment.More than treatment month, patient's dizziness, the symptom such as weak are obviously improved, and the soreness of waist, gastral cavilty distension etc. alleviates, stool 3-4 times/day.After one and a half months, check laboratory indexes: serum creatinine 539.6 μ mol/L, blood urea nitrogen 57.68mmol/L, routine blood test: erythrocyte 3.76 × 10
12/ L, hematochrome 120g/L.The state of an illness is clearly better, and leaves hospital.So far more than 1 year, carry out institute's check, feel fair, biochemical indicator is basicly stable.
case 2:
Soup so-and-so, female, 49 years old, teacher, main suit: more than anasarca companion cardiopalmus, the June of feeling sick, increase the weight of a week.History of present illness: edge patient finds renal dysfunction when living city institute because of cardiopalmus, edema with coronary heart disease on April 18th, 2003, and turn more than Nephrology hospitalization half a year, in outer court, look into Scr855.6 μ mol/L, Bun38.5mmol/L, HGB98g/L, B ultrasonic and ECT all point out: two kidney volume-diminished, are chronic kidney hypofunction and change.Because symptom increases the weight of day by day, be reluctant again to accept hemodialysis and Lai Wo institute seeks medical advice.Inscribe disease opinion: complexion is black dull not well, pitch-black as panda eye shape near the eyes, anasarca is with lower limb for very, and nausea and vomiting is done frequently, palpitation and insomnia, and sensation of oppression over the chest with shortness of breath, lossless, oliguria <500ml/24h, constipation with dry stool is not smooth.Picture of the tongue: dimly pale tongue, the large limit of corpulent tongue has tooth to print, and tongue fur is white thick greasy and dirty, and the root of the tongue is rotten swollen.Pulse condition sinks thin, two chi thready and weak pulse without strength.Health check-up: T37.1 ℃, P72 beat/min, R21 beat/min, BP142/88mmHg.Urine examination: yellow skin muddiness, Pro+2, WBC+1, coarse granular cast 0-2/HP.Blood examination: WBC11.20 × 109/L, HGB98g/L, RBC3.09 × 109/L.Western medicine diagnose: chronic renal failure.Tcm diagnosis: obstruction and rejection, edema.Chinese medical discrimination: spleen suffer from a deficiency of the kidney decline, turbid malicious stasis blocking.Therapeutic Principle: invigorating spleen and kidney, toxin expelling the turbid descending.Therapeutic Method: give our treatment after one week, nausea and vomiting disappears, and appetite is improved, and edema alleviates, and has sweating, and urine amount increases, free movement of the bowels, separates 3 day and half congealed, and picture of the tongue greasy coating has turned to thin white and greasy fur, thready pulse.29, on November is looked into Scr208 μ mol/L in treatment to 1997, BuN8.28mmol/L, and urine amount is increased to 2000 milliliters of above/24h, and General Symptoms obviously improves.After 6 months, look into SCr140 μ mol/L, BuN8.21mmol/L, HGB110g/L.All cards disappear substantially, and can do a little houseworks, continue with top after treatment nearly 8 years so far, and all cards are all pacified, and renal function index is normal or approach normal.
case 3:
Lee, man, 31 years old.Patient goes out to appear tired in June, 2007, weak, occasionally there is edema of pair of lower extremities, companion feels sick, poor appetite, to local hospital creatinine 326 umol/L that have a blood test, hematochrome 40g/L, urine protein 3+, 3+ occults blood, be diagnosed as " chronic renal insufficiency ", creatinine 415 umol/L have a blood test, take Hai Kun Sheng Xi Capsule, open equal Drug therapy, and Yu Jiazhong interruption is taken treatment by Chinese herbs, the state of an illness is still without improving, the tired power of body increases the weight of, in August, 2007 at creatinine 817 umol/L that have a blood test of certain hospital, suggestion hemodialysis, because suffering from " epidermolysis bullosa ", fail to accept dialysis treatment, Yu Jiazhong interruption is taken treatment by Chinese herbs, on May 16th, 2008, the tired power of patient's body further increases the weight of, the local hospital pigment 22g/L that has a blood test, serum creatinine is not tested.
After being admitted to hospital, have a medical check-up: while being admitted to hospital, mind is clear, spirit is poor, anemia looks, body is tired, weak, breathes hard, with feeling sick, vomiting, poor appetite; urine 1000ml/ day, blood pressure 130/80mmHg, the visible sheet of the whole skin incrustation of festering; conjunctiva is pale, and two pulmonary respiration sounds are slightly thick, news and dry moist rale; 100 beats/min of hearts rate, in mitral area audible and III/6 grade systole blowing murmur, two lower limb slight depression edema.Lab testing: routine blood test: erythrocyte 1.47 × 1012/L, hemoglobin 45g/L, routine urinalysis: occult blood+1, occult blood+2, leukocyte+3 blood biochemistry: CO2 combining power, CO2 CP 14.54mmol/L, blood urea nitrogen 61.1mmol/L, creatinine 1171.0 umol/L, B ultrasonic: 1. pair kidney diffuse lesion, 2. liver, gallbladder, spleen no abnormality seen, 3. Bicuspid valve backflows on a small quantity.
Treatment situation: give this preparation prescription and adjust, 1 dose of every day (be equivalent to granulation agent every day 30 grams), until be in hospital 16 days, sanity when patient leaves hospital, spirit better, receiving dormancy can, two just adjust, twenty-four-hour urine amount is about 1700 milliliters, the vital sign of having a medical check-up is steady, check routine blood test: erythrocyte 3.84 × 1012/L, hemoglobin 114g/L, routine urinalysis: occult blood+-, occult blood+1, blood biochemistry: blood urea nitrogen 12.00mmol/L, creatinine 162.80 umol/L, conditions of patients is clearly better, be in hospital 101 days, Influence Factors of Taking Medicine at Discharge is after treatment in family, after three months, pay a return visit patient's serum creatinine 130 umol.
diagnostic criteria:
(1) acute nephritis fails thoroughly to control, clinical symptoms and uroscopy protracted course of disease reach 1 year above this; (2) there is obvious type nephritis history in the past (at least exceeding 1 year), and due to acute upper respiratory tract infection, in a couple of days, symptom and the sign person of acute attack appears again in (being no more than 1 week); (3) previously without obvious nephritis medical history, engender symptom and the sign person of chronic nephritis or renal failure; (4) non-evident sympton, only, when physical examination or inspection other diseases, finding has albumen, the pathology sign persons such as erythrocyte or cast in urine.
criterion of therapeutical effect:
(1) take a turn for the better: transference cure after treatment, sign disappears or alleviates, and anemia is improved, and surrounding hemogram hematochrome rises, and erythrocyte increases, and blood urea nitrogen obviously declines, and acidosis obtains rectifier.(2) unchanged: the state of an illness still belongs to stable, transference cure, sign alleviates, but anemia do not feel any better, and blood urea nitrogen loses decline, has chronic acidosic shower.(3) worsen: uremia's symptom does not subtract, and azotemia increases the weight of, and acidosis increases the weight of, and is carrying out property anemia, and occur infecting, hemorrhage, heart failure, pericarditis, electrolyte disturbance, the clinical manifestation persons such as urine retention.(4) death.
Table 1-19 is shown in following subordinate list.
Subordinate list
impact (n=12, the unit: g) of table 1 preparation granules of the present invention on Adenine-Induced Chronic Renal Failure in Rat animal pattern body weight
Note: t-check, with relatively * of model control group
p< 0.05 * *
p< 0.01; Be administered to the 3rd week and start to carry out each treated animal index detection, therefore last week cannot carry out body weight statistics.
Claims (1)
1. a Chinese patent medicine for the treatment of chronic renal failure, is characterized in that: it is to be prepared from according to following weight parts proportioning and method by crude drug Radix Pseudostellariae, the Radix Astragali, Radix Rehmanniae, Fructus Corni, Rhizoma Alismatis, Poria, Rhizoma Dioscoreae, Radix Salviae Miltiorrhizae, Radix Et Rhizoma Rhei and Fructus Amomi:
Proportioning: 375 parts of Radix Pseudostellariaes, 187.5 parts of the Radixs Astragali, 187.5 parts of Radix Rehmanniae, 187.5 parts of Fructus Corni, 187.5 parts of Rhizoma Alismatis, 187.5 parts, Poria, 125 parts of Rhizoma Dioscoreaes, 375 parts of Radix Salviae Miltiorrhizaes, 125 parts of Radix Et Rhizoma Rhei, 75 parts of Fructus Amomis;
Preparation method:
The first step, pulverizes Fructus Amomi, adds 6 times of amounts of water, and steam distillation 6 hours extracts volatile oil, and medicinal residues and aqueous solution are continued to employ;
Second step, by cold preservation after betacyclodextrin inclusion 24 hours for first step gained volatile oil, filters, standby after cold drying;
The 3rd step, the medicinal residues that the first step is continued to employ decoct with water three times together with residue nine taste medicines, after the aqueous solution that filtrate and the first step are continued to employ merges, are concentrated into the thick paste of relative density 1.3-1.35, are ground into fine powder after drying under reduced pressure;
The 4th step, will add 10 parts of aspartames after second step and the 3rd step gained material mix homogeneously, and dextrin is appropriate, routinely technique mix homogeneously, granulation, obtain Chinese patent medicine after dry.
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| Title |
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| 杨卫彬.益肾化浊液治疗慢性肾衰61例.《中医研究》.1998,第11卷(第3期),21-23. |
| 益肾化浊液治疗慢性肾衰61例;杨卫彬;《中医研究》;19980630;第11卷(第3期);21-23 * |
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